The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medical Device Evaluation Consultation” for public comment on May 20, 2016, with comments solicitation period concluding on June 5, 2016. For future product registration – according to these draft guidelines – face-to-face consultation shall be limited to 3 sessions of 30 minutes’ consultation with the CMDE reviewer. All consultations are to be scheduled online, pending confirmation from the CMDE reviewer. Online consultations are limited to just one per company, per product. Phone consultation duration and schedule remains the same – limited to 1 hour per call, every Monday and Wednesday afternoons. The draft appears to imply that enquiries beyond the scope of Input Requests (Supplementary Note) are likely not to be entertained.
Sad, huh?
Why? Its objectives?
Considering the practical condition of medical device evaluation, it is drawn up to improve the quality and efficiency of the registration and evaluation of medical devices and to standardise the consultation of medical device evaluation.
Scope
1.The extent of consultation
It is mainly for medical device registrations that have summited application and are in the state of input request. After receiving the supplementary note from CMDE, applicant / registrant can consult about the notification before supplementing the materials.
2.The extent of queries
It is aimed at questions about the supplementary note mentioned in “Confirmation of MDE Face-to-Face Consultation”. Questions beyond the scope of supplementary note may not be entertained. The consultation will not confirm the supplementary materials to be submitted by the applicant / registrant. Results of the registration evaluation is only based on the submitted supplementary materials.
3.Non-Applicable Products
According to “Emergency Approval Procedure of Medical Devices”, “Innovation of Special Approval Procedure of Medical Devices(The Draft)” and other regulations, the evaluation counselling will be arranged otherwise.
4.Consulting Methods?
1) Face-to-face consultation
2) Online consultation
3) Telephone enquiry
4) General Q & A
The Lowdown….
1.Face-to-face Consultation
- Limit of consulting: Face-to-face consultation for each qualified acceptance number shall be limited to 3 sessions
- Counselling sessions: 9:00-11:30, 13:30-16:30 every Thursday. Enquiry duration for each application is within 30 minutes.
- Application process
- In special cases:
If the reviewer is unable to attend the consultation, he/she should inform the applicant 2 days earlier than the appointed time for a re-arrangement.
If the reviewer will be in long absence due to illness, job transfer or other reasons, department officials should make corresponding adjustment.
2.Online Consultation
- Applicable conditions: Enquiries about registration that are simple and easy to answer.
- Limit of consulting: Each qualified acceptance number can only apply for online consultation once.
- Reply time: Within 20 working days from the date the application is received
- In special cases:
- If necessary, reviewer can submit the replies online after the confirmation of department officials (or technical committee branch);
- Online consultation can be switched to face-to-face consultation if the reviewer think the latter one is more suitable for the applicant / registrant.
3.Telephone Enquiry
- Applicable conditions: It is mainly for the content of supplementary note and some of the enquiries about medical device registration evaluation.
- Counselling sessions: 15:30-16:30 every Monday and Wednesday
- Phone number: You can get the office number through the billboard on CMDE official website. (Follow CMDRA on WeChat, send “CMDE” and then get in touch with review staff.)
- In special cases: If necessary, under the guidance of review staff, applicant / registrant can apply for face-to-face consultation through the consulting platform on centre website.
4.General Q & A
- Applicable conditions: General questions that frequently appear during a period of time should be collected by reviewer for analysis, and regularly concluded and summarised by every department. Upon the confirmation by department staff (or technical committee branch), these general questions will be answered.
- In special cases: If department staff (or technical committee branch) think it necessary to discuss with central technical committee, the answers will be released according to their decisions after discussion.
When & Who?
Deadline for feedback: June 5, 2016
Contact: Zhang Shiqing
Tel: (86)1068390732
Email: zhangsq@cmde.org.cn
For written mail: Center For Medical Device Evaluation SFDA, Room 301, Unit B3, Building No.5, No.9, Chegongzhuangda Street, Xicheng District, Beijing
Post code: 100044
Chapter 1・General
Rule 1
Considering practical condition of evaluation, it is drawn up to improve the quality and efficiency of the registration and evaluation of medical devices and to standardise the consultation of medical device evaluation.
Rule 2
Counselling of medical device evaluation includes face-to-face consultation, online consultation, telephone enquiry and general Q & A.
Rule 3
Scope of consultation: It is mainly for medical device registration that have summited application and are in the state of input request/supplementary note. After receiving the supplementary note from CMDE, applicant / registrant can consult about the notification before supplementing the materials.
The consultation will not confirm the supplementary materials to be submitted by the applicant / registrant. Results of the registration evaluation is only based on the submitted supplementary materials.
Rule 4
Quality administration is in charge of integrated management of counselling. Each evaluation department is in charge of its counselling management. The office is to provide technical support for central website consulting platform.
Chapter 2・Face-to-Face Consultation
Rule 5
The applicant / registrant can make online appointment via online consulting platform by duly filling in “Enquiry Application Form (Appendix 1)” and claiming enquiries. Face-to-face consultation for each qualified acceptance number shall be limited to 3 sessions
Rule 6
Once the reviewer receives face-to-face consultation application, he/she should arrange the appointment in time via central website consulting platform as well as notify the applicant via phone call 3 days earlier. In principle, face-to-face consultation should be done within 20 working days from the date when the application is received.
Rule 7
The applicant can check the application result via online consulting platform. Once it is approved, he/she can print the “Confirmation Note of Face-to-face Consultation of Medical Device Evaluation” (Appendix 2) in duplicate as voucher.
Rule 8
Normally face-to-face Consultation is held during 9:00-11:30, 13:30-16:30 every Thursday. The reviewer shall estimate the consultation duration in advance, which should not exceed 30 minutes under normal circumstances. Face-to-face consultations to be held by the same reviewer is more likely to be arranged at the same time.
After face-to-face consultation, the “Confirmative Note of Face-to-face Consultation of Medical Device Evaluation” should be signed by both sides and be kept respectively.
Rule 9
If the reviewer is unable to attend the consultation In some special cases, he/she should communicate with the applicant 2 days earlier than the appointment for a re-arrangement.
Rule 10
In the event of long absence due to illness, job transfer or other reasons, department officials should make corresponding adjustment for the absent reviewer.
Rule 11
The reviewer should know about the “Enquiry Application Form” in advance and prepare for face-to-face consultation. It is suggested to communicate about projects that involve two-person or penal review ahead of time and, if necessary, company representatives of the applicant are allowed to attend the consultation.
Rule 12
Requirements of face-to-face consultation
(1) should fully consider the requirements’ principle of science and rationality according to the existing laws and regulations, answer questions mentioned in the supplementary materials of “Enquiry Application Form of Face-to-face Consultation of Medical Device Evaluation”. The receptionists can avoid answering questions beyond the scope of the supplementary note.
(2) should be punctual and neatly dressed, courteous and law-abiding, paying attention to the applicant’s opinions and questions with patience. Their answers should be accurate and explicit without ambiguity.
Chapter 3・Online Consultation
Rule 13
The online consultation, which is requested by the applicant / registrant through central website consulting platform, is mainly for questions that are simple and easy to reply. Each qualified acceptance can only apply for online consultation once.
Rule 14
The review should accomplish online consultation within 20 working days from the date when the application is received. If necessary, reviewer can submit the replies online after being confirmed department officials (or technical committee branch).
Online consultation can be switched to face-to-face consultation if the reviewer think the latter one is more suitable for the applicant / registrant. Please refer to the relevant requirements mentioned in Chapter 2.
Rule 15
Replies and suggestions provided by online consultation should be professional and concise without ambiguity. The reviewer may not answer questions beyond the scope of supplementary note, other than the questions about the supplementary materials in the “Enquiry Application Form”.
Chapter 4・Telephone Enquiry
Rule 16
It mainly applies to questions mentioned in the supplementary note and doubts about medical device evaluation. If necessary, applicant / registrant can apply for face-to-face consultation under the guidance of reviewing staff, through online consulting platform.
Rule 17
Normally it is held during 15:30-16:30 every Monday and Wednesday. Office number can be reached through the central website billboard.
Chapter 5・General Q&A
Rule 18
General questions that frequently appear during a period of time should be collected by reviewer for analysis, and regularly analysed and summarised by each department. These questions will be answered, upon the confirmation by department staff (or technical committee branch). If department staff (or technical committee branch) think it necessary to discuss with central technical committee, according to their decisions after discussion, the answers will be released once every season.
Chapter 6・Supplementary Provisions
Rule 19
Once The Guidelines are released, staff in each central segment, must not accept any consultation in the reviewing office under normal circumstances.
Rule 20
According to “Emergency Procedure of Medical Device Evaluation”, “The Requirements of Application Materials for Special Approval of Innovative Medical Devices (Draft)” and other regulations, consultation about evaluation will be otherwise arranged.
Rule 21
The right to interpret The Guidelines resides in CMDE.
Rule 22
The Guidelines shall go into effect on the date of promulgation. Meanwhile, “Guidelines for the Management of Medical Device Evaluation Consultation” released on March 26, 2007 is superceded.
